Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits

Completed · Not applicable · Has a placebo group

Conditions studied: Upper Extremity Paresis, Stroke, Chronic

In brief

This is a single-center, multiphase pilot study of 16 subjects with residual upper extremity deficits at least six months after a supratentorial ischemic or hemorrhagic stroke. The purpose of the study is to evaluate the clinical safety, device functionality, and treatment effect of non-invasive electrical stimulation of the trigeminal and/or vagus nerves (nTVNS) using the NeuraStasis Stimulator System adjunctive to rehabilitation. Phase 1 consisted of 5 unblinded subjects receiving nTVNS to assess device usability and safety. Phase 2 used a Prospective Randomized Open, Blinded Endpoint (PROBE) design comparing nTVNS to sham stimulation in 11 subjects. The study will inform the design and implementation of a pivotal study.

Key facts

Study ID: NCT06288217
Run by: NeuraStasis, Inc
People needed: 16
Starts: 2024-03-05
Expected to finish: 2025-11-13
Last updated by the study team: 2026-06-02

Who can join

Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

History of unilateral supratentorial ischemic, intracerebral hemorrhagic, subarachnoid hemorrhagic, or a heterogeneous lesion stroke that occurred at least 6 months but not more than 15 years prior to enrollment.
Age >30 years and <85 years.
Fugl-Meyer Assessment, Upper Limb (FMA-UE) baseline score of 10 to 56 (inclusive of 10 and 56).
Ability to communicate, understand, and provide appropriate consent. Subjects should be able to follow two-step commands.
Right- or left-sided weakness of the upper extremity.

You may not qualify if…

Participant with any implanted metallic device at or near the stimulation sites (forehead and ears).
Participant with an implanted or active stimulator (ex. Deep brain stimulator, pacemaker, vagus nerve stimulator, defibrillator)
Participant skin in the stimulation area has open wounds, skin eruptions, swollen, infected, or inflamed areas, or skin abnormalities that could be cancerous
Advanced cardiac, pulmonary, liver, kidney dysfunction or blood system disease
Participant has a fever or shows clinical signs concerning for an infectious disease
Other neurologic or musculoskeletal diseases that could interfere with the assessments of this study
Low heart rate (<60 bpm) from a cardiac conduction block or related etiology
Participant has a history of trigeminal neuralgia
Participant has a history of Bell's Palsy
History of cranial nerve neuropathy (including facial nerve injury), carotid surgery, vagotomy, or other surgical intervention on the vagus nerve
History of recurrent syncopal events
Known or newly-discovered aneurysm or arteriovenous malformation
Patients who have any terminal illness such that the patient would not be expected to survive more than 90 days
Botox injections 12 weeks prior to or during therapy
Participants who have had a craniectomy:
Without replacement of bone flap
With bone flap replaced < 6 months prior to initiation of study activities

Where it is running

The University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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